Role Purpose:This position will drive the execution of Market Access strategies specific to the Edwards BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. The successful candidate will drive
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Customer Consulting Team design, build & implement customer centric solutions. We bring the expertise in customer-focus, market, domain, technology, data, and project management, working closely with solution sellers, product managers and other subject matter authorities in-order to
Company Description Who is Turner & Townsend? All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every
Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題（役割分担等）の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題／問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する知識がある方 Experience 企業での業務経験のある方（分析、製造、CMC薬事、開発等）（3年以上が望ましい） Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的 The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
Job Purpose: Responsible for driving commercial success in Japan LOC by leading GSK X-functional team Member of the Global/LOC cross-functional, shaping global strategy and co-creation Key Responsibilities: Understand global strategy and initiatives, as well as local
Let’s be #BrilliantTogether Overview: We are seeking a Research Associate to join our Governance Research Team for Korean Market to deliver excellent corporate governance research the helps investors manage their governance opportunities and risks . Responsibilities:
Do you enjoy taking ownership of projects to ensure success? 確実な成功に向けたプロジェクトのオーナーシップを楽しんでいますか? Our progress as a team and planet is intertwined. Are you ready to join us and take energy forward? チームの進歩と地球は密接に関係しています。私たちと一緒にエネルギー業界を前進させませんか? Join our Team 私たちのチームに参加してください。 Quest
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
About the Role: Position Summary We are looking for candidates with a passion for technology and financial markets, who have strong problem-solving skills and a talent for communication. Our platforms provide the industry-leading services for OTC derivatives
Meta is seeking a proactive and hands-on hardware focused Channel/Sales Operations Planner to support our Distribution Partners responsible for reselling to B2B Partners (Retail, Enterprise, Carriers). The successful candidate will have the opportunity to support an
About Zscaler Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange is the company’s cloud-native platform that protects thousands of customers from cyberattacks
8/6 days only roster | FIFO from Perth to the Roy Hill Mine Family friendly even time roster to achieve true life/work balance Employee travel benefits for FIFO employees – airport parking, flights, accommodation Company contribution
The Product Strategy & Planning department at Thomson Reuters is the department that examines, plans, and implements the Companys product and service offerings to better serve its customers. About the Role As the Product Planning Specialist,
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
◆部門: HEOR (Health Economic Outcome Research) IQVIAのコアアセットである医療ビッグデータ、及びテクノロジーを駆使した革新的新薬の市販後観察研究、PMS、Health Economics & Outcome Research(HEOR)研究などのエビデンスジェネレーションを推進 ◆業務内容 Real World Evidence(RWES)を使用した複数のプロジェクトのマネジメントや他領域におけるRWESを実務としたプロジェクトチームのリードやチームの参画。 与えられたリソースを基に、プロジェクトの目標を達成/成功させるべく企画からマネジメントまで運営 詳細な情報を記した専門的な文書（例：RWE Study Protocols and Statistical Analysis Plans）の発展をリード 高品質な調査と分析を遂行するようチームを先導し、クライアントやステークホルダーに全てのプロジェクトにおいて高い品質と成功をコミット クライアントの新規事業開発における識別と道筋を示し、事業の発展に寄与 ◆論文執筆事例: Japanese Direct-to-Consumer (DTC) genetic testing service An exploratory assessment of the applicability
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
